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Erector Spinae Regional Anesthesia for Pain Control

Sponsor
The University of Texas Health Science Center at San Antonio (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05794828
Collaborator
(none)
40
Enrollment
1
Arm
12
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Interventional study to use erector spinae plane block (ESPB) on diagnoses of posterior or lateral rib fractures, vertebral fractures, pancreatitis, pancreatic cancer, renal colic, and back pain for multimodal pain therapy to determine its assistance with pain relief as well as the patient's use of opiates after block completion

Condition or Disease Intervention/Treatment Phase
  • Drug: Bupivacaine Injection
 Phase 1/Phase 2

Detailed Description

Patients with the listed diagnoses will be offered and then consented for an ESPB under ultrasound guidance. They will rate their pain before and 30 minutes after the procedure using the ordinal categorical data on a numeric pain scale. Total patient opiate use will be gathered up to 8 hours after block completion.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single group open label assignmentSingle group open label assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Erector Spinae Regional Anesthesia for Pain Control in the Emergency Department
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Erector Spinae Plane Block (ESP) administration

Patients with the listed diagnoses will be offered and then consented for an ESPB under ultrasound guidance.

Drug: Bupivacaine Injection
Bucivacaine will be administered intramuscularly according to package insert directions after first numbing the area with lidocaine subcutaneously
Other Names:
  • Bupivacaine Hydrochloride Injection

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain Scale Rating [Baseline to study procedure end (approximately 30 minutes)]

      Change in pain scale rating assessed by the participants on a scale from 0-10 with 0 indicating no pain and 10 indicating the most severe pain.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Posterior/lateral rib or vertebral fractures

    • Pancreatitis or pancreatic cancer

    • Renal colic

    • Back pain

    Exclusion Criteria:

    • Unstable vitals

    • Infection or open wound over insertion site

    • Prior allergic reaction to local anesthetic

    • Pregnant females

    • Patients <18 years old

    • Altered mentation

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • The University of Texas Health Science Center at San Antonio

    Investigators

    • Principal Investigator: Morgan Ritz, MD, University of Texas Health Science Center San Antonio

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The University of Texas Health Science Center at San Antonio
    ClinicalTrials.gov Identifier:
    NCT05794828
    Other Study ID Numbers:
    • HSC20220911H
    First Posted:
    Apr 3, 2023
    Last Update Posted:
    Apr 3, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by The University of Texas Health Science Center at San Antonio
    Erector spinae plane block
    ESPB
    Pain reduction
    Additional relevant MeSH terms:
    Bupivacaine

    Study Results

    No Results Posted as of Apr 3, 2023